CHU de Bordeaux, Hôpital Haut-Lévêque, Service d'Hépato-gastroentérologie, Pessac, France.
Inflamm Bowel Dis. 2011 Jan;17(1):69-76. doi: 10.1002/ibd.21405.
Infliximab is the only medical therapy that has been proven to be effective in fistulizing Crohn's disease (CD), but the recurrence rate of fistulas is high despite maintenance therapy. The aim of this prospective study was to evaluate the short- and long-term efficacy of a combined schedule with infliximab, methotrexate, and sphincter-sparing surgery in patients with severe fistulizing anoperineal CD.
From January 2006 to November 2007, all consecutive patients in three referral centers with severe fistulizing anoperineal CD were prospectively included after primary drainage. At inclusion, patients received three infliximab infusions at weeks 0, 2, and 6, and maintenance therapy with methotrexate. A second optimized surgical step consisting of at least removal of setons was performed between the second and the third infliximab infusions.
Thirty-four CD patients (26 women; median age 38.5 years) with complex anoperineal fistula were enrolled (including 9 with recto-vaginal fistulas, and 10 with anorectal stenosis). At week 14 the response rate was 85% with 74% complete responders. At 1 year, 50% were still responders; luminal CD worsening was the major cause of relapse. Median Perineal Disease Activity Index (PDAI) and magnetic resonance imaging (MRI) scores significantly decreased from baseline to week 50.
A combined approach with infliximab induction, two surgical sphincter-sparing steps and methotrexate is effective in achieving short-term response in severe fistulizing anoperineal CD. The best maintenance regimen remains to be determined.
英夫利昔单抗是唯一被证明对瘘管性克罗恩病（CD）有效的医学治疗方法，但尽管进行了维持治疗，瘘管的复发率仍然很高。本前瞻性研究旨在评估英夫利昔单抗、甲氨蝶呤和括约肌保留手术联合方案在严重肛门直肠瘘管性 CD 患者中的短期和长期疗效。
从 2006 年 1 月至 2007 年 11 月，在三个转诊中心，所有经初次引流的严重肛门直肠瘘管性 CD 连续患者均前瞻性纳入。纳入时，患者在第 0、2 和 6 周接受三次英夫利昔单抗输注，并接受甲氨蝶呤维持治疗。在第二次和第三次英夫利昔单抗输注之间进行第二次优化手术，至少切除皮筋。
34 例（26 例女性；中位年龄 38.5 岁）复杂肛门直肠瘘管性 CD 患者入组（包括 9 例直肠阴道瘘和 10 例肛门直肠狭窄）。第 14 周时，应答率为 85%，完全应答率为 74%。1 年后，仍有 50%的患者有应答；肠腔 CD 恶化是复发的主要原因。中位会阴疾病活动指数（PDAI）和磁共振成像（MRI）评分从基线显著降低到第 50 周。
英夫利昔单抗诱导、两次括约肌保留手术和甲氨蝶呤联合方案治疗严重肛门直肠瘘管性 CD 可在短期内获得应答。最佳维持治疗方案仍有待确定。
